Guidelines for Clinical Trial

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Document Name Updated
Guidelines for Good Clinical Practice (GCP) Inspection Second Edition Aug-18
Malaysian Guideline for Phase I Unit Inspection and Accreditation Programme Jun-18
Malaysian Guidelines for Good Clinical Practice 4th Edition Jan-18
The Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption, edition 6.4 Aug-17
Senarai Jawatankuasa Etika Yang Berdaftar Dengan PBKD Nov-16
Malaysian Guideline for Independent Ethics Committee Registration and Inspection, First Edition Jun-16
Malaysia Guideline for BE Inspection, First Edition Oct-14
Malaysian Guideline for Safety Reporting of Investigational Products, First Edition Oct-14